Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
- Registration Number
- NCT00327600
- Lead Sponsor
- AmpliMed Corporation
- Brief Summary
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Malignant melanoma; inoperable stage III or IV disease.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 4 months.
- If female, neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
- Blood cell counts and blood chemistries in or near normal range.
- Prior radiation is permitted.
- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No other current drug therapy for the cancer or steroid therapy.
- No prior chemotherapy for the stage III or IV disease.
- Brain metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description imexon + DTIC DTIC - imexon + DTIC imexon -
- Primary Outcome Measures
Name Time Method Determine the maximally tolerated dose of imexon plus DTIC determine the toxicity and tolerability of the combination determine response rate and progression free survival
- Secondary Outcome Measures
Name Time Method Determine effects of the drug combination on plasma thiol levels and other biomarkers
Trial Locations
- Locations (11)
University of CO Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Investigational Site 012
🇺🇸Salt Lake City, Utah, United States
US Oncology Greenville, Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Investigational Site 009
🇺🇸Los Angeles, California, United States
US Oncology, Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Investigational Site 002
🇺🇸Santa Monica, California, United States
US Oncology Albany, New York Oncology
🇺🇸Albany, New York, United States
US Oncology Orlando, Cancer Centers of FL
🇺🇸Ocoee, Florida, United States
US Oncology Kettering
🇺🇸Kettering, Ohio, United States
US Oncology, Virginia Oncology Assoc
🇺🇸Norfolk, Virginia, United States
US Oncology Spokane, Cancer Care Northwest
🇺🇸Spokane, Washington, United States